Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

Stroke Clinical Trial

Official title:

Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02437006
• Other study ID #: KMUH-IRB- 20130376
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2015
• Last updated: May 4, 2015
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2014
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Miao-Ju Hsu, PHD
• Phone: 88673121101
• Email: mjhsu[@]kmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial Summary

This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. The second stage would recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). They are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

Description:

This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.The second stage would recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three groups. The control group undergoes traditional rehabilitation only, The low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. The The high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. They are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• stroke onset longer than two weeks,

• eligible for exercise testing by Doctor

Exclusion Criteria:

• aphasia,

• apraxia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• exercise
cycle ergometry

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University, College of Health Sciences	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change values of symptom-limit exercise capacity	value was showed by oxygen uptake (mL/kg/min)	baseline and after four-week training	No
Secondary	change values of sympathetic nerve tests	change value was measure by blood pressure (from lying to stand, mm-Hg) at baseline and after four weeks	baseline and after four-week training	No